World Malaria Day 2015

Malaria

WHO: World Malaria Day: a call to close gaps in prevention and treatment
23 April 2015 — For World Malaria Day, 25 April, WHO calls on the global health community to urgently address significant gaps in the prevention, diagnosis and treatment of malaria. Despite dramatic declines in malaria cases and deaths since 2000, more than half a million lives are still lost to this preventable disease each year.
Read the news release about World Malaria Day

European Vaccine Initiative Watch [to 25 April 2015]
http://www.euvaccine.eu/news-events
:: World Malaria Day 2015: We can further bring down deaths from malaria by concerted global action
25 April 2015
‘European Vaccine Initiative urges to sustain funding and political commitment to ensure continued success in combatting malaria’.

The Lancet – Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial

The Lancet
Online First
Comment
Final results from a pivotal phase 3 malaria vaccine trial
Vasee S Moorthy, Jean-Marie Okwo-Bele
Published Online: 23 April 2015
DOI: http://dx.doi.org/10.1016/S0140-6736(15)60767-X
Summary
In The Lancet, the RTS,S Clinical Trials Partnership1 report the most recent results from the pivotal phase 3 trial of RTS,S/AS01 malaria vaccine, the fourth major publication from this randomised controlled trial.2–4 The trial enrolled 15,459 infants and young children at 11 centres in seven sub-Saharan African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania. Two age groups were included: 6–12 weeks and 5–17 months at first dose. The schedule involved a primary series of three monthly doses, with a booster dose given 18 months later in one of the three trial groups.

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Articles
Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial
RTS,S Clinical Trials Partnership – Members listed at end of paper
Published Online: 23 April 2015
DOI: http://dx.doi.org/10.1016/S0140-6736(15)60721-8
Summary
Background
The efficacy and safety of the RTS,S/AS01 candidate malaria vaccine during 18 months of follow-up have been published previously. Herein, we report the final results from the same trial, including the efficacy of a booster dose.
Methods
From March 27, 2009, until Jan 31, 2011, children (age 5–17 months) and young infants (age 6–12 weeks) were enrolled at 11 centres in seven countries in sub-Saharan Africa. Participants were randomly assigned (1:1:1) at first vaccination by block randomisation with minimisation by centre to receive three doses of RTS,S/AS01 at months 0, 1, and 2 and a booster dose at month 20 (R3R group); three doses of RTS,S/AS01 and a dose of comparator vaccine at month 20 (R3C group); or a comparator vaccine at months 0, 1, 2, and 20 (C3C [control group]). Participants were followed up until Jan 31, 2014. Cases of clinical and severe malaria were captured through passive case detection. Serious adverse events (SAEs) were recorded. Analyses were by modified intention to treat and per protocol. The coprimary endpoints were the occurrence of malaria over 12 months after dose 3 in each age category. In this final analysis, we present data for the efficacy of the booster on the occurrence of malaria. Vaccine efficacy (VE) against clinical malaria was analysed by negative binomial regression and against severe malaria by relative risk reduction. This trial is registered with ClinicalTrials.gov, number NCT00866619.
Findings
8922 children and 6537 young infants were included in the modified intention-to-treat analyses. Children were followed up for a median of 48 months (IQR 39–50) and young infants for 38 months (34–41) after dose 1. From month 0 until study end, compared with 9585 episodes of clinical malaria that met the primary case definition in children in the C3C group, 6616 episodes occurred in the R3R group (VE 36•3%, 95% CI 31•8–40•5) and 7396 occurred in the R3C group (28•3%, 23•3–32•9); compared with 171 children who experienced at least one episode of severe malaria in the C3C group, 116 children experienced at least one episode of severe malaria in the R3R group (32•2%, 13•7 to 46•9) and 169 in the R3C group (1•1%, −23•0 to 20•5). In young infants, compared with 6170 episodes of clinical malaria that met the primary case definition in the C3C group, 4993 episodes occurred in the R3R group (VE 25•9%, 95% CI 19•9–31•5) and 5444 occurred in the R3C group (18•3%, 11•7–24•4); and compared with 116 infants who experienced at least one episode of severe malaria in the C3C group, 96 infants experienced at least one episode of severe malaria in the R3R group (17•3%, 95% CI −9•4 to 37•5) and 104 in the R3C group (10•3%, −17•9 to 31•8). In children, 1774 cases of clinical malaria were averted per 1000 children (95% CI 1387–2186) in the R3R group and 1363 per 1000 children (995–1797) in the R3C group. The numbers of cases averted per 1000 young infants were 983 (95% CI 592–1337) in the R3R group and 558 (158–926) in the R3C group. The frequency of SAEs overall was balanced between groups. However, meningitis was reported as a SAE in 22 children: 11 in the R3R group, ten in the R3C group, and one in the C3C group. The incidence of generalised convulsive seizures within 7 days of RTS,S/AS01 booster was 2•2 per 1000 doses in young infants and 2•5 per 1000 doses in children.
Interpretation
RTS,S/AS01 prevented a substantial number of cases of clinical malaria over a 3–4 year period in young infants and children when administered with or without a booster dose. Efficacy was enhanced by the administration of a booster dose in both age categories. Thus, the vaccine has the potential to make a substantial contribution to malaria control when used in combination with other effective control measures, especially in areas of high transmission.
Funding
GlaxoSmithKline Biologicals SA and the PATH Malaria Vaccine Initiative.

GSK – Malaria vaccine candidate has demonstrated efficacy over 3-4 years of follow-up

GSK – Malaria vaccine candidate has demonstrated efficacy over 3-4 years of follow-up
24 April 2015
– Final results from Phase III trial suggest substantial public health benefits could be provided by the RTS,S malaria vaccine candidate in endemic regions in sub-Saharan Africa
– Vaccine efficacy enhanced by administration of a booster dose

Final results from a large-scale Phase III trial of the RTS,S malaria vaccine candidate, including the impact of a booster dose, published today in The Lancet, show that the vaccine candidate helped protect children and infants from clinical malaria for at least three years after first vaccination.

The latest results demonstrated that vaccination with RTS,S, followed by a booster dose of RTS,S administered 18 months after the primary schedule, reduced the number of cases of clinical malaria in children (aged 5-17 months at first vaccination) by 36% to the end of the study1 (over an average follow-up of 48 months across trial sites) and in infants (aged 6-12 weeks at first vaccination) by 26% to the end of the study (over an average follow-up of 38 months across trial sites). Efficacy decreased over time in both age groups. Without the booster dose, the 3-dose primary schedule reduced clinical malaria cases by 28% in children and 18% in infants to the study end. The efficacy of RTS,S was evaluated in the context of existing malaria control measures, such as insecticide treated bed nets, which were used by approximately 80% of the children and infants in the trial.

For children in the 5-17 month age category who received a booster dose 18 months after the primary schedule, an average of 1,774 cases of clinical malaria were prevented for every 1,000 children vaccinated across the trial sites, over an average of 48 months of follow-up. For infants aged 6-12 weeks at first vaccination with RTS,S, who received a booster dose, 983 cases of clinical malaria, on average, were prevented for every 1,000 infants vaccinated across trial sites over an average of 38 months of follow-up. More cases were averted in areas of higher malaria transmission. In the absence of a booster dose, 1,363 cases of clinical malaria were prevented, on average, for every 1,000 children aged 5-17 months at first vaccination and 558 cases for every 1,000 infants aged 6-12 weeks at first vaccination to the end of the study.

Statistically significant efficacy against severe malaria to the end of the study period was observed only in children who received the booster dose. There was indication of increased risk for severe malaria in children who did not receive the booster dose, compared to those in the control group.

Eleven research centres in seven African countries2 conducted the efficacy and safety trial, in partnership with GSK and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI. The trial, started in March 2009 and concluded in January 2014, enrolled 15,459 participants, in two age categories: children (aged 5-17 months at first vaccination) and infants (aged 6-12 weeks at first vaccination).

Safety
RTS,S continued to display an acceptable safety and tolerability profile during the entire study period.

The incidence of fever in the week after vaccination was higher in children who received RTS,S than in those receiving control vaccine. In some children who experienced fever, the febrile reaction was accompanied by generalized convulsions, but all those affected fully recovered within seven days.

The meningitis signal previously reported remains in the older age category, including two cases reported after the booster dose of RTS,S. This could be a chance finding, as comparisons were made across groups for many different diseases, and because some of these cases happened years after vaccination without any obvious relationship to vaccination. The occurrence of meningitis will be followed closely during Phase IV studies, if RTS,S is licensed.

Dr Kwaku Poku Asante, a principal investigator in the trial and chairperson of the RTS,S Clinical Trials Partnership Committeesaid “We finally have in our sights a candidate vaccine that could have a real impact on this terrible disease that affects many children during their first years of life. The large number of children affected by malaria, sometimes several times per year, means that this vaccine candidate, if deployed correctly, has the potential to prevent millions of cases of malaria.

On behalf of the African scientists and research centers that worked on the RTS,S trial, we give thanks to our national health authorities, and to the trial participants, for enabling us to reach this important milestone.”

Dr Moncef Slaoui, Chairman Global Vaccines at GSK, said: “We are extremely encouraged that the results point to continued and significant public health benefit for those children whose lives are so disrupted by this awful disease. We might reasonably now expect that the impact of this vaccine candidate when used with existing interventions will allow more children to survive the early years which we know is the most dangerous time to be infected with malaria. We are working hard to submit the necessary evidence to regulatory authorities and the World Health Organisation so that they can take an informed decision on whether the RTS,S vaccine candidate should be made available as an additional tool for malaria prevention.”

Dr David C. Kaslow, Vice President of Product Development at PATH, said: “Credit for reaching this scientific milestone goes to the thousands of African families and hundreds of scientists, clinicians, and health professionals who have made a commitment for many years to this vaccine trial. The public-private partnership behind RTS,S has successfully collected pivotal human efficacy and safety data that regulators and policymakers can now use to decide on its use. While eradication is the ultimate goal, malaria has yet to be eliminated or even fully controlled in many parts of the world; these data suggest that malaria vaccines can help us take some critical steps along that path.”

Next steps
The European Medicines Agency (EMA) is currently reviewing the regulatory application for RTS,S through the Art. 58 procedure initiated in July 2014.
A positive opinion from the EMA’s Committee for Medicinal Products for Human Use, together with a potential policy recommendation from the World Health Organisation (anticipated by the end of 2015), would be the basis for licensure applications to National Regulatory Authorities in sub-Saharan African countries. If positive, these regulatory decisions would help pave the way for the introduction of RTS,S through African national immunisation programmes. If RTS,S is approved, GSK has committed to making the vaccine available at a not-for-profit price.

WHO & Regionals [to 25 April 2015]

WHO & Regionals [to 25 April 2015]
:: Sixty-eighth World Health Assembly – 18–26 May 2015

Stories from Countries
:: India drives down malaria rates, sets sights on elimination
24 April 2015
:: Ebola diaries: Creating ways to understand an outbreak
24 April 2015
:: Improved blood systems in Ebola-affected countries expected to be positive outcome
21 April 2015

:: The Weekly Epidemiological Record (WER) 24 April 2015, vol. 90, 17 (pp. 169–184) includes:
:: Polio surveillance: tracking progress towards eradication worldwide, 2013–2014
:: Performance of acute flaccid paralysis (AFP) surveillance and incidence of poliomyelitis, 2015

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:: WHO Regional Offices
WHO African Region AFRO
:: WHO Regional Director for Africa Dr Matshidiso Moeti concludes her visit to Liberia
Monrovia, 24 April 2015 – The WHO Regional Director for Africa Dr Matshidiso Moeti has wrapped up her 3 day official visit to Liberia with a courtesy call on the President of Liberia, Her Excellency, Mrs. Ellen Johnson Sirleaf. Welcoming Dr Moeti, the President congratulated her for having been elected as Regional Director of WHO for the African Region. She also expressed her gratitude to WHO for being a good partner in health development and said that the organization has contributed tremendously in building capacity for Ebola virus Disease outbreak response…
:: A child dies every minute from malaria in Africa – 24 April 2015
:: Zambia’s First Lady launches African Vaccination Week in Lusaka – 23 April 2015
WHO Region of the Americas PAHO
:: Vaccination Week in the Americas will target 60 million children and adults (04/22/2015)
WHO South-East Asia Region SEARO
:: Close the immunization gap
Progress towards global vaccination targets for 2015 is far off-track with 1 in 5 children still missing out on routine life-saving immunizations that could avert 1.5 million deaths each year from preventable diseases. WHO is calling for renewed efforts to get progress back on course.
WHO European Region EURO
:: Towards a malaria-free European Region by the end of 2015 24-04-2015
:: Poor indoor environments at school 23-04-2015
:: First meeting of the European Health Information Initiative: working together to improve information for better health 20-04-2015
:: Stronger action required on environmental pollutants 20-04-2015
WHO Eastern Mediterranean Region EMRO
:: WHO warns of imminent collapse of health care services in Yemen
21 April 2015, Cairo, Egypt – WHO warns of an imminent collapse of health care services in Yemen. Health facilities are struggling to function as they face increasing shortages of life-saving medicines and vital health supplies, frequent disruptions in power supply and lack of fuel for generators. Lack of fuel has also disrupted functionality of ambulances and the delivery of health supplies across the country.
:: Keeping Syrian children free from polio at home and across the border
21 April 2015
:: WHO continues to address health needs of affected populations in Anbar; appeals for funding
20 April 2015
WHO Western Pacific Region
:: World Malaria Day 2015: Protecting and strengthening gains for a malaria-free future
Dr Shin Young-soo discusses malaria surveillance in Xekong Province, the Lao People’s Democratic Republic.
MANILA, 24 April 2015 – With the theme “Invest in the future, defeat malaria”, the World Health Organization (WHO) in the Western Pacific Region urges Member States to consolidate recent gains against malaria and accelerate efforts towards a malaria-free Region.

MSF launched a global campaign – A FAIR SHOT :: GSK Responds

MSF launched a global campaign – A FAIR SHOT
MSF said the campaign is intended “…to call on pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) to reduce the price of the pneumococcal vaccine (PCV) in developing countries to US$5 per child, so more children can be protected from this childhood killer, and to disclose the price that the companies currently charge countries and humanitarian medical providers for the vaccine.”
MSF said the campaign urges the public to #AskPharma for transparency in their pricing as well as for the pneumococcal vaccine (PCV) to cost US$5 per child, so that governments and MSF can vaccinate more children…supported by MSF’s latest report on vaccine pricing and access.

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GSK response to MSF vaccine report
20 January 2015
More children from the world’s poorest countries are being vaccinated against more diseases than ever before. This is a good thing and has been made possible by unprecedented cooperation between governments, NGOs and pharmaceutical companies.

Around 80% of all of GSK’s vaccines, including our pneumococcal vaccine, are provided to developing countries at a substantial discount to western prices. We offer our lowest prices to Gavi and UNICEF which can be as little as a tenth of developed world prices. At the same time, we have comprehensive vaccine research programmes in critical areas that affect poor countries such as malaria, TB, HIV and Ebola.

Many of our available vaccines are advanced and complex and require significant upfront capital investment to make and supply. Our pneumococcal vaccine is one of the most complex we’ve ever manufactured, essentially combining 10 vaccines in one. For Gavi-eligible countries, we are providing this vaccine at a deeply discounted price. At this level, we are able to just cover our costs. To discount it further would threaten our ability to supply it to these countries in the long-term. Nevertheless, we continue to look at ways to reduce production costs and any savings we make we would pass on to Gavi.

We also continue to look at other opportunities to support vaccination in developing countries. This week for example we committed to a ten-year price freeze for countries that graduate from Gavi support due to increased economic wealth to help ensure that children can continue to be vaccinated. We also entered into an agreement to supply doses of our pneumococcal vaccine at a nominal cost to MSF to immunise children caught up in ongoing crises.

Global Fund [to 25 April 2015]

Global Fund [to 25 April 2015]
http://www.theglobalfund.org/en/mediacenter/newsreleases/
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24 April 2015
Gavi and the Global Fund Welcome Malaria Vaccine Trial Results

22 April 2015
Net Campaign Targets Universal Coverage in Niger

20 April 2015
Global Fund Launches Online Platform for Strategy Development
GENEVA – The Global Fund partnership has launched a consultation as part of a process to engage a wide range of stakeholders in developing its 2017-2021 strategy.
Through a web platform launched today, the Global Fund seeks to involve a broad spectrum of participants from government, civil society, people affected by the diseases, multilaterals, private sector and other interested parties to collectively shape the future of the partnership through contributing to the making of the new strategy.

The e-Forum 2015 will invite participants to discuss and share their thinking on diverse thematic areas that the Global Fund works in while highlighting how the partnership should prepare itself for changing dynamics in global health. The e-Forum will be a multilingual platform and will be hosted on the website http://theglobalfund-eforum.org/consultation .
Through the forum participants will have an opportunity to shape the future of the Global Fund partnership with its mission of ending AIDS, tuberculosis and malaria as epidemics, while building resilient health systems and community responses.

The e-Forum is one strand in a broad consultative process which will also include Global Fund convened meetings across three continents – Africa, Asia and Latin America. Partners will gather in these venues to explore ways of guiding the Global Fund partnership to achieve much greater impact. There will be additional consultation opportunities alongside meetings hosted by WHO, UNAIDS, PMNCH and the StopTB Partnership…